MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-04-24 for MATRIXMANDIBLE PLATE BENDING PLIERS-LEFT 03.503.041 manufactured by Synthes Tuttlingen.
[73458161]
Additional narrative: patient information is unknown. Date of event is unknown. Device is an instrument and is not implanted/explanted. A device history record review was performed for the subject device lot number t944992. Manufacturing location: (b)(4). Date of manufacture: 01-apr-2010. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[73458162]
It was reported that while performing a routine inspection of the set, it was noticed that there is a little chip missing out of one of the teeth in the matrixmandible plate bending pliers, left. No patient involvement. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[75935566]
A product development investigation was performed. A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation. This complaint is confirmed. A corner of the distal ledge that aligns plates has sheared off of one of the jaws. The sheared off fragment was not returned. Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken. No new malfunctions were identified as a result of the investigation. The returned matrixmandible plate bending pliers-left are a reusable instrument in the matrix mandible plating system used to aid in contouring plates to fit patient anatomy. Relevant drawing was reviewed during this investigation. No product design issues or discrepancies were observed. Unable to determine a definitive root cause. It is most likely the result of cumulative wear for this 7 year old reusable bending plier. No new, unique or different patient harms were identified as a result of this evaluation. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. There was no known reported patient involvement associated with the complained event. (b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680938-2017-10068 |
| MDR Report Key | 6515224 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-24 |
| Date of Report | 2017-03-28 |
| Date Mfgr Received | 2017-05-03 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2017-04-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MATRIXMANDIBLE PLATE BENDING PLIERS-LEFT |
| Generic Name | INSTR,BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2017-04-24 |
| Returned To Mfg | 2017-04-04 |
| Catalog Number | 03.503.041 |
| Lot Number | T944992 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-24 |